Chronic Obstructive Pulmonary Disease, COPDNCT06928805
The Effects of Two Different Breathing Techniques and Forward-Leaning Position on Physiological Parameters
A study testing Balloon inflation exercise and Pursed-lip breathing exercise in people with Chronic Obstructive Pulmonary Disease, COPD, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study aims to determine the effects of balloon inflation and pursed-lip breathing exercises, in addition to the forward-leaning position, on physiological parameters in individuals with Chronic Obstructive Pulmonary Disease (COPD). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, COPD
- What is being tested?
- Balloon inflation exercise and Pursed-lip breathing exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jan 2024to 2 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have no communication and cooperation problems,
- Can speak and understand Turkish,
- Have a baseline saturation of >90%,
- Have been diagnosed with Stage II and Stage III COPD,
- Have not had any infection or COPD exacerbation for at least 3 months,
- Have not participated in a pulmonary rehabilitation program in the last 3 months,
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- Can walk without assistance,
- Do not have serious and/or unstable heart disease, neuromuscular disease, orthopedic disease or mental illness that may impair their physical activities of daily living,
- Willing to participate in the study will be included.
Who cannot join
- Patients who have been hospitalized since the start of the study,
- Those receiving continuous oxygen therapy,
- Those who have cooperation problems,
- Those who cannot adapt to exercise,
- Those who have 2-3 or more acute attacks per year,
- Those with a history of pulmonary hypertension, malignancy, pulmonary thromboembolism, obstructive sleep apnea, unstable angina or myocardial infarction,
- Patients with a pulse rate over 120/minute will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Turkey
Istanbul, Üsküdar
About this study
Official title: Determination of the Effects of Two Different Breathing Techniques and Forward-Leaning Position on Physiological Parameters in Patients With Chronic Obstructive Pulmonary Disease
This study aims to determine the effects of balloon inflation and pursed-lip breathing exercises, in addition to the forward-leaning position, on physiological parameters in individuals with Chronic Obstructive Pulmonary Disease (COPD).
The hypotheses of the study are as follows:
Read more
H1_1: The forward-leaning position and balloon inflation breathing exercise have a positive effect on physiological parameters in patients with Chronic Obstructive Pulmonary Disease (COPD).
H1_2: The forward-leaning position and pursed-lip breathing exercise have a positive effect on physiological parameters in patients with COPD.
H1_3: There is a significant difference in physiological parameters between the balloon inflation and pursed-lip breathing exercise groups and the control group.
Within this scope, the study will be conducted with three groups:
Intervention Group 1: Balloon inflation exercise applied in addition to the forward-leaning position.
Intervention Group 2: Pursed-lip breathing exercise applied in addition to the forward-leaning position.
Control Group: Standard practice implemented in the institution where the study is conducted.
Participants:
- A home exercise program will be designed for both intervention groups, allowing them to perform the exercises independently each day.
- The exercises will start with three sessions per day and will be increased by one session each week, continuing for a total of four weeks.
- Participants will visit the outpatient clinic in the 4th week for assessments and tests.
- Patients will be contacted weekly by the researcher via phone to ensure adherence to the program.
Read the detailed description
The exercise program will be determined in collaboration with a respiratory physiotherapist and implemented by the researcher. Accordingly, patients with stage II-III COPD (as determined by a physician) who visit the pulmonology outpatient clinic of the relevant hospital and meet the inclusion criteria will be given brief information about respiratory exercises, their benefits, and duration. They will then be instructed on how to perform the exercises through verbal commands for approximately 30 minutes. At the end of the session, the exercise guidelines will be practiced under the supervision of the researcher.
Before starting, the patient will be seated in a chair and allowed to rest for about 15 minutes. The patient will be informed about how to perform the walking test, the expected walking pace, and that they can stop and rest if they feel fatigued. Then, the patient will be asked to walk at a brisk pace for six minutes under the supervision of the researcher. During the walk, the researcher will continuously monitor the patient's oxygen saturation using a handheld pulse oximeter. If the patient exhibits signs of excessive sweating, pallor, or a significant drop in oxygen levels, the test will be terminated early.
Before and after the test, blood pressure, pulse rate, respiratory rate, oxygen saturation [SpO2], and dyspnea score using the Modified Borg Scale will be assessed, and the distance the patient walks in six minutes will be recorded. The six-minute walk test will be repeated at the end of the study. Subsequently, the patient will undergo a pulmonary function test, and the values for FVC, FEV1, FEV1/FVC ratio, and peak expiratory flow will be recorded.
- Being tested
- Balloon inflation exercise, Pursed-lip breathing exercise, Control (Standard treatment)
- Keywords
- Chronic Obstructive Pulmonary Disease, Breathing Techniques, Forward-Leaning Position, Physiological Parameters
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon inflation exerciseOther
Balloon inflation exercise was applied in addition to the forward-leaning position.
Pursed-lip breathing exerciseOther
The pursed-lip breathing exercise was applied in addition to the forward-leaning position.
Control (Standard treatment)Other
Standard practice is implemented in the institution where the study is conducted.
| Study group | Role | What they receive |
|---|---|---|
| Pursed-lip breathing exercise | Experimental | Not described Receives: Other: Pursed-lip breathing exercise |
| Balloon inflation exercise | Experimental | Not described Receives: Other: Balloon inflation exercise |
| Standard treatment | Experimental | Not described Receives: Other: Control (Standard treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure
Measured: 4 weeks later
pulse
Measured: 4 weeks later
respiratory rate
Measured: 4 weeks later
saturation
Measured: 4 weeks later
Secondary outcomes (6)
Forced Vital Capacity (FVC)
Measured: 4 weeks later
Forced Expiratory Volume in One Second (FEV1)
Measured: 4 weeks later
FEV1/FVC ratio
Measured: 4 weeks later
Peak Expiratory Flow (PEF)
Measured: 4 weeks later
Modified Borg Dyspnea Scale (MBS)
MBS determines the severity of dyspnea at rest and during exertion. It consists of 10 items that define the severity of dyspnea according to its degree. A score of 0 indicates no dyspnea, and a score of 10 indicates very severe dyspnea.
Measured: 4 weeks later
6 Minute Walking Test (6MWT)
The test evaluates functional exercise capacity by measuring the distance in meters that the patient will cover in 6 minutes by walking as fast as possible but without running in a 30-meter uninterrupted corridor.
Measured: 4 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start3 Jan 2024
- Primary completion4 Jan 2025
- Study completion2 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease, COPDStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Semra Aciksoz, RN, Assistant Professor, PhD, Principal investigator, University of Health Sciences Turkey, Hamidiye Faculty ofNursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928805
- Sponsor's protocol ID
- SaglikBilimleriU Semra Aciksoz
- Status last verified
- Mar 2025
- First submitted
- 28 Mar 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Effects of Two Different Breathing Techniques and Forward-Leaning Position on Physiological Parameters in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06928805
- Acronym / sponsor ID
- SaglikBilimleriU Semra Aciksoz
- Keywords
- Chronic Obstructive Pulmonary Disease, Breathing Techniques, Forward-Leaning Position, Physiological Parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 4 Jan 2025 (actual)
- Study completion
- 2 Feb 2025 (actual)
- First posted
- 15 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine the effects of balloon inflation and pursed-lip breathing exercises, in addition to the forward-leaning position, on physiological parameters in individuals with Chronic Obstructive Pulmonary Disease (COPD).
The hypotheses of the study are as follows:
H1_1: The forward-leaning position and balloon inflation breathing exercise have a positive effect on physiological parameters in patients with Chronic Obstructive Pulmonary Disease (COPD).
H1_2: The forward-leaning position and pursed-lip breathing exercise have a positive effect on physiological parameters in patients with COPD.
H1_3: There is a significant difference in physiological parameters between the balloon inflation and pursed-lip breathing exercise groups and the control group.
Within this scope, the study will be conducted with three groups:
Intervention Group 1: Balloon inflation exercise applied in addition to the forward-leaning position.
Intervention Group 2: Pursed-lip breathing exercise applied in addition to the forward-leaning position.
Control Group: Standard practice implemented in the institution where the study is conducted.
Participants:
- A home exercise program will be designed for both intervention groups, allowing them to perform the exercises independently each day.
- The exercises will start with three sessions per day and will be increased by one session each week, continuing for a total of four weeks.
- Participants will visit the outpatient clinic in the 4th week for assessments and tests.
- Patients will be contacted weekly by the researcher via phone to ensure adherence to the program.
Detailed description
The exercise program will be determined in collaboration with a respiratory physiotherapist and implemented by the researcher. Accordingly, patients with stage II-III COPD (as determined by a physician) who visit the pulmonology outpatient clinic of the relevant hospital and meet the inclusion criteria will be given brief information about respiratory exercises, their benefits, and duration. They will then be instructed on how to perform the exercises through verbal commands for approximately 30 minutes. At the end of the session, the exercise guidelines will be practiced under the supervision of the researcher.
Before starting, the patient will be seated in a chair and allowed to rest for about 15 minutes. The patient will be informed about how to perform the walking test, the expected walking pace, and that they can stop and rest if they feel fatigued. Then, the patient will be asked to walk at a brisk pace for six minutes under the supervision of the researcher. During the walk, the researcher will continuously monitor the patient's oxygen saturation using a handheld pulse oximeter. If the patient exhibits signs of excessive sweating, pallor, or a significant drop in oxygen levels, the test will be terminated early.
Before and after the test, blood pressure, pulse rate, respiratory rate, oxygen saturation [SpO2], and dyspnea score using the Modified Borg Scale will be assessed, and the distance the patient walks in six minutes will be recorded. The six-minute walk test will be repeated at the end of the study. Subsequently, the patient will undergo a pulmonary function test, and the values for FVC, FEV1, FEV1/FVC ratio, and peak expiratory flow will be recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pursed-lip breathing exercise | Experimental | Other: Pursed-lip breathing exercise |
| Balloon inflation exercise | Experimental | Other: Balloon inflation exercise |
| Standard treatment | Experimental | Other: Control (Standard treatment) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients who have no communication and cooperation problems,
- Can speak and understand Turkish,
- Have a baseline saturation of >90%,
- Have been diagnosed with Stage II and Stage III COPD,
- Have not had any infection or COPD exacerbation for at least 3 months,
Key exclusion criteria (7 listed)
- Patients who have been hospitalized since the start of the study,
- Those receiving continuous oxygen therapy,
- Those who have cooperation problems,
- Those who cannot adapt to exercise,
- Those who have 2-3 or more acute attacks per year,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balloon inflation exerciseBalloon inflation exercise was applied in addition to the forward-leaning position. | Other | Balloon inflation exercise |
| Pursed-lip breathing exerciseThe pursed-lip breathing exercise was applied in addition to the forward-leaning position. | Other | Pursed-lip breathing exercise |
| Control (Standard treatment)Standard practice is implemented in the institution where the study is conducted. | Other | Standard treatment |
Primary outcome
blood pressure
Time frame: 4 weeks later
pulse
Time frame: 4 weeks later
respiratory rate
Time frame: 4 weeks later
saturation
Time frame: 4 weeks later
6 secondary outcomes
Forced Vital Capacity (FVC)
Time frame: 4 weeks later
Forced Expiratory Volume in One Second (FEV1)
Time frame: 4 weeks later
FEV1/FVC ratio
Time frame: 4 weeks later
Peak Expiratory Flow (PEF)
Time frame: 4 weeks later
Modified Borg Dyspnea Scale (MBS)
Time frame: 4 weeks later
6 Minute Walking Test (6MWT)
Time frame: 4 weeks later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Semra Aciksoz, RN, Assistant Professor, PhD principal investigator
University of Health Sciences Turkey, Hamidiye Faculty ofNursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balloon inflation exercise and Pursed-lip breathing exercise in people with Chronic Obstructive Pulmonary Disease, COPD, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood pressure (time frame: 4 weeks later). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.